Getting Medicare to Cover CGMs: What You Can Do

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Medicare (CMS) does not cover the cost of a continuous glucose monitor (CGM), no matter how great the person’s need for it. Finally able to bring your blood sugar under control by using a CGM? Had multiple episodes of severe hypoglycemia before using it? Sorry, a CGM is not covered. Unable to tell when you are becoming hypoglycemic, a state called hypoglycemia unawareness, which also means that your body is unable to help defend you from becoming hypoglycemic, or allow you to recover from hypoglycemia? Too bad, a CGM is still not covered. Already using a CGM successfully and now become a Medicare beneficiary, perhaps after surviving decades of having type 1 diabetes? Congratulations on surviving a deadly disease, welcome to Medicare….now give up your CGM. Or figure out how to pay for it on your own.

A bill has been introduced to both houses of congress that would force CMS to pay for CGMs when it is indicated, and pave the way for coverage of closed loop ‘artificial pancreas’ devices now in development. I would urge you to go to the JDRF website and sign a petition in support of these bills, and more importantly, to contact your two senators and congressional representative and urge them to support or co-sponsor these bills. And once you do that, try and get everyone you know to do the same. There are between 1-2 million people with type 1 diabetes in the US—let’s make some noise! This injustice has to stop.

If you are a Medicare beneficiary, you can appeal a denial of CGM coverage. The first 2 levels almost always are decided against the patient, but do not give up. The third level is decided by an Administrative Law Judge (ALJ), and they can reverse the non-coverage decision based on individual circumstances. It is usually a live hearing conducted over the phone at a scheduled time, and that gives you a chance to argue your case, and have an advocate argue on your behalf as well. I would urge you to submit as much medical evidence as you can to the ALJ, and be very specific about what the problems you have had, and the benefits you have gotten from a CGM if you are already using it. A download of your data can also demonstrate why you still need it, especially if it shows that you get wide swings in blood glucose levels, or episodes of hypoglycemia that are detected and prevented. If you have had a professional CGM session ordered by your doctor, and it shows hypoglycemia or wide swings in blood sugar, that evidence can help as well. Your doctor can also provide either a letter or live testimony if they are willing. The letter below could be copied and pasted out and provided to your doctor, if you could email it, it would be even better so they can copy it directly, put it on their own letterhead, and modify as they see fit. You can also download it as a Word document here. It contains the general arguments. They should also add why you in particular would or have been benefit from a CGM.

Beware: if you win before an ALJ, CMS has 60 days to appeal, and they usually do, and tend to do it at the last minute, and only give you 10 days to respond again. Keep fighting! You also have the option of getting a lawyer. You would want to make sure they have experience in dealing with CMS denials.

Letter Sample:

To Whom it May Concern:

I believe that my patient,__________________, warrants CGM coverage for the following reasons:

(add specific indications and circumstances for the person here)

CMS currently does not cover Continuous Glucose Monitoring (CGM) for home use. CMS is essentially the last major insurer that will not cover, under any circumstances, this proven, cost effective, life-saving technology for type 1 diabetes patients (T1D). A peer reviewed retrospective study (Endocrine Practice 2014;20: 1297-1302) demonstrated that insulin-requiring patients who are 65 years old or older who use personal CGM (PCGM) can derive clinically significant improvements in glycemic control in real world clinical practice, with a significant and durable improvement in A1c. The reduction in A1c was comparable to those reported in studies of younger patients. Most importantly, it showed reductions in both the percent reporting severe hypoglycemia episodes, and a marked reduction in the frequency of severe hypoglycemia per patient.

Formal cost benefit analysis has shown that a CGM is cost effective. Diabetic patients generate medical cost about 4 times per capita that of a non-diabetic, and 2/3 of the extra costs are due to treating complications of diabetes. Full-time use of a CGM costs about $400 a month. A day in the hospital costs about $2000, a broken hip caused by hypoglycemia costs about $68,000, and dialysis costs about $72,000 a year. The premature loss of a life cannot be priced. The prevention of the terror that hypoglycemia, an unavoidable consequence of current type 1 diabetes therapy, induces is also not priced into these considerations.

Insulin-requiring patients that have reached Medicare age tend to have a longer duration of diabetes and are thus more likely to have significant micro- and macrovascular complications and suffer from other co-morbidities. It has been reported that T1D patients over age 60, in addition to having higher rates of diabetes complications, had nearly twice the incidence of severe hypoglycemia compared to younger T1D patients. The T1D Exchange Clinic Registry reported that patients over 65 had a high yearly rate of severe hypoglycemia, which was mostly accounted for by the long diabetes duration in many patients in that age group (J Clin Endocrinol Metab, August 2013, 98(8):3411–3419). Severe hypoglycemia can be particularly dangerous in older patients and is associated with increases in the risks of falls with injury, myocardial infarcts, arrhythmias, temporary or permanent cognitive impairment, seizures, motor vehicle accidents, and death (Diabetes Care 2013: 36:1384–1395). Hypoglycemia that occurs to someone while driving can and does cause serious motor vehicle accidents, which can result in serious injury, permanent disability, and death to both the driver and others. Hypoglycemia while driving is no longer a risk to the individual; it is a public health menace, putting all of us at risk.

The American Diabetes Association suggests modifying glycemic goals in diabetic patients with a short life expectancy, a history of severe hypoglycemia despite intervention, or a high burden of co-morbidities. However, patients reaching Medicare age do not necessarily fall into any of these groups. Furthermore, patients with higher A1C levels continue to have a significant risk of severe hypoglycemia, indicating that using higher A1C goals is not sufficient protection against severe hypoglycemia (J Clin Endocrinol Metab, August 2013, 98(8):3411–3419). The Endocrine Society has endorsed the use of CGMs in adults who will use them on a nearly daily basis, and site high quality evidence that supports this stance (Continuous Glucose Monitoring: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011;96: 2968–2979). A CGM is the current standard of care. Currently, the Center for Medicare and Medicaid Services does not cover them, despite high quality evidence that it is beneficial, but intermittent professional CGM may be covered, despite limited evidence that intermittent CGM is useful in T1D. In contrast, nearly all private insurers will cover CGMs, and they sometimes provide coverage for them in patients on Medicare. In the study mentioned above, most Medicare age patients who continued to use CGMs had insurance coverage, either from a secondary insurance policy or because they were still working and had work-related primary insurance coverage, and most that did not have supplemental insurance cited cost as the primary factor. Some continue to work after age 65 or even 70 because the only way they can afford to continue on CGM is with work-related coverage. It should also be mentioned that CMS covers not only people over 65, but those on disability, such as someone who might have received a renal transplant due to diabetes. Does it make sense to not provide such a person the access to a vital tool which is afforded others, to prevent the transplanted kidney from failing again?

CMS has deemed the CGM to be “precautionary.” It is no more precautionary than putting working brakes on a car. It has also been deemed a “convenience.” That designation flies in the face of a large body of high quality evidence of benefit from peer reviewed medical studies. Even patients who do everything right with type 1 diabetes are still subject to the risk of severe hypoglycemia at night or while driving. One cannot check a fingerstick while asleep, no matter how determined the patient may be. And a fingerstick only tells you were the current blood sugar is, not where it is going, and how fast. That is the essential difference between a fingerstick blood sugar and a CGM reading. There simply is no comparison.

In summary, not covering a CGM is not medically justifiable, denies T1D patients access to the current standard of care, and is likely to increase costs to CMS. This policy is unfair, even cruel to T1D patients covered by CMS, whether based on age or disability. CMS is the last major insurer in the US which does not cover them. Other insurers do not cover them because they feel sorry for T1D patients; they cover it because it makes economic and medical sense. Patients with type 1 diabetes who reach Medicare age are often long-term survivors of a deadly disease, and they face growing risk of costly complications and need protection from dangerous bouts of severe hypoglycemia. They deserve and warrant better than a denial from CMS. My patient,__________________, warrants CGM coverage.

Respectfully submitted,

______________________

 

In my view, the current CMS non coverage policy is a disgrace. It denies access to the current standard of care to one of the type 1 populations with the greatest need. I hope this information helps you to fight back.

Nicholas B. Argento MD–Dr Nick

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